MelanomaOpen to EnrollmentPhase 3

UVEAL MELANOMA: METASTATIC: 1st line: RP2-202: REVEAL

A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

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Study snapshot

Title: Replimune RP2-202 Uveal melanom
Malignancy: Uveal melanoma, Ocular melanoma, Eye melanoma
Stage: Stage 4
Disease setting: Metastatic/Unresectable
Line of therapy: 1st Line
Investigational agent: RP2
Drug class: Oncolytic immunotherapy
Principal investigator: Arnel Pallera
Sponsor: Replimune
Path: Uveal melanoma
Randomized: Yes
ClinicalTrials.gov ID: NCT06581406

Eligibility and objectives

Key eligibility criteria details

Confirmed metastatic uveal melanoma not amenable to surgical resection
At least 1 measurable and injectable tumor of > or = 1 cm in longest diameter (1.5 cm in short axis for a lymph node)
LDH <2x ULH
ECOG PS 0-1
No prior exposure to PD-1 agents
No known HBV/HCV/HIV
No CNS involvement

Objective

Primary
- OS
- PFS
Secondary
- AE
- ORR
- DCR

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details